FDA label e2cb283a-3a15-451a-b832-3bff536809fe

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
aac71d6a-b423-4d88-bc9e-3ef747bef253
SPL ID
e2cb283a-3a15-451a-b832-3bff536809fe
Version
2
Effective date
2017-05-09
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:48:29

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings: Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting, consult a doctor promptly. Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma or emphysema, a cough accompanied by excessive phlegm (mucus). Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, cough lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days. These could be signs of a serious condition. Keep out of Reach of Children: Keep out of reach of children. Ask the Doctor: Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma or emphysema, a cough accompanied by excessive phlegm (mucus). Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, cough lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days.These could be signs of a serious condition. Pregnancy or Breast Feeding: If pregnant or breast-feeding, ask a healthcare professional before use.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.